Abstract

To evaluate vision related quality of life in the patients enrolled in The European Consortium for the Early Treatment of Diabetic Retinopathy, a clinical trial on prevention of diabetic retinopathy. Four-hundred-forty-nine patients, 153 women, with type 2 Diabetes and no or mild diabetic retinopathy were enrolled in a 2-year multicenter randomized controlled trial. The 25-item National Eye Institute Visual Functioning Questionnaire was used to explore 12 subscales of vision related quality of life. The patients were 62.8 ± 6.7 years old and had 11.1 ± 5.6 years known disease duration. Diabetic retinopathy was absent in 193 (43.0 %) and mild in 256 (57.0 %). Patients without diabetic retinopathy were older, had shorter diabetes duration and used less insulin and glucose-lowering agents but did not differ by gender, best corrected visual acuity or any subscale, except vision specific mental health and vision specific role difficulties. Patients with reduced retinal thickness at the ganglion cell layer (n = 36) did not differ for diabetic retinopathy but were older, had lower best corrected visual acuity and worse scores for ocular pain, color vision and peripheral vision. On multivariable analysis, worse scores for general vision remained associated with reduced retinal thickness, diabetes duration and best corrected visual acuity, and scores for visual specific mental health with diabetic retinopathy and lower best corrected visual acuity. Visual specific role difficulties were only associated with reduced best corrected visual acuity. Scores for driving decreased among females, with worsening of Hemoglobin A1c and best corrected visual acuity. Color vision depended only on reduced retinal thickness, and peripheral vision on both reduced thickness and best corrected visual acuity. The National Eye Institute Visual Functioning Questionnaire could detect subtle changes in patients’ perception of visual function, despite absent/minimal diabetic retinopathy.